Evaluating the Safeness of Trivalent Subunit Inactivated... | NCT01123954

Studies
Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers

NCT01123954

Sponsor

Novartis Vaccines

Status

Completed

Last Update Posted

Dec 14, 2011Estimated

Enrollment

33Actual

Phase

Phase 2

Conditions

Seasonal Influenza

Interventions

Seasonal flu vaccine

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Mar 24, 2010

First Submission Date that Met QC Criteria

May 13, 2010

First Posted Date

May 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2011

Last Update Posted Date

Dec 14, 2011Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Other		Biological: Seasonal flu vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Seasonal flu vaccine	Biological	This phase II is performed as a monocenter study site in a population of healthy subjects aged 1 to 45 years. Enrolled subjects received one single IM dose of trivalent subunit inactivated influenza vaccine during the vaccination visit, according to the study protocol (follow-up period: 30 days)

Measure	Description	Time Frame
Using the single vaccination for volunteers and follow up within 30 days since the first vaccination to evaluate levels of safety (AEs) after vaccination		30 days, including the follow-up period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy people with aged 1 to 45 years;
Previous history of not being vaccinated by any flu vaccines;
Women of childbearing potential agree to apply the contraceptive measures during the study period;
Do not have any acute or chronic diseases by screening;
Having the abilities of understanding and conforming the study plan;
Volunteer to the study;
Agree to vaccinate completely and conform the follow up procedure within 30 days after the first vaccination.

Exclusion Criteria:

Having the suspected symptoms of infecting flu: cough, sore throat, stuffy or running nose, headache, malaise, myalgia and arthralgia, weakness, chilly or sweat;
A prior history of allergy to any components of candidate vaccine;
Sensitive to eggs or chicken protein, kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80;
Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
Being immuno deficiency due to treatment;
Using immunosuppressive drugs (belong to steroid group) within 06 months before vaccination;
Being sickness or cancer or HIV (+);
Participating in other study on drug or vaccination;
Receipt of other vaccine within 04 weeks before participating in the study;
Congenital malformation, mental disorder or members of family having the mental disorder;
Using immune globulin or blood products within 03 months before vaccination;
Having an acute or chronic diseases that can cause influence on the safety including: hepatic, renal, mental diseases or diabetes and transplantation;
Body temperature over 37.5 degree Celcius within 01 week before vaccination;
History of alcohol or drugs addicted within 05 years;
Planning to travel away from the study site among the visits.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided